Unspecified Adult Solid Tumor, Protocol SpecificNCT02895490
Communication Training in Promoting Employment Retention Among Cancer Patients
A study testing educational intervention, communication skills training and questionnaire administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This randomized clinical trial studies communication training in promoting employment retention among cancer patients. Communication training may improve patient-employer communication and increase the likelihood that cancer patients will remain employed, reduce patients' time away from work, and increase workplace… Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- educational intervention, communication skills training and questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a new, primary diagnosis of a solid tumor
- Employed full- or part-time at the time of enrollment
- English-speaking
- Able to participate in telephone interviews
- Able to view a 1-hour DVD
- Patients must have a treatment plan that includes chemotherapy and be within 2 weeks of initiating chemotherapy
Who cannot join
- Patients with prior cancer except non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Using Communication Training to Promote Employment Retention Among Cancer Survivors
This randomized clinical trial studies communication training in promoting employment retention among cancer patients. Communication training may improve patient-employer communication and increase the likelihood that cancer patients will remain employed, reduce patients' time away from work, and increase workplace accommodations that enable patients to balance treatment and work.
Read the detailed description
PRIMARY OBJECTIVES:
- Demonstrate the efficacy of the DVD intervention to a) increase patients' knowledge of their legal rights in the workplace, b) improve patient perceptions of workplace communication about the impact of cancer treatment and ongoing surveillance, and c) increase the number of requested and received workplace accommodations.
II. Compare employment status (employed vs non-employed) between the treatment and control arms.
III. Compare weekly hours of work between the treatment and control arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients receive a DVD containing educational information about patients' legal rights in the workplace and communication skills demonstrated through four scenarios depicting a variety of employer-employee communication challenges for patients, provided by the Legal Information Network for Cancer (LINC) group.
Arm II: Patients receive information about the LINC group
After completion of study, patients are followed up at 4, 12, and 52 weeks.
- Being tested
- educational intervention, communication skills training, questionnaire administration, quality-of-life assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Receive a DVD containing educational information and communication skills
communication skills trainingOther
Receive a DVD containing educational information and communication skills
educational interventionOther
Also called intervention, educational
Receive information about the LINC group
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (DVD) | Experimental | Patients receive a DVD containing educational information about patients' legal rights in the workplace and communication skills demonstrated through four scenarios depicting a variety of employer-employee communication challenges for patients, provided by LINC group. Receives: Other: educational intervention; Other: communication skills training; Other: questionnaire administration; Other: quality-of-life assessment |
| Arm II (control) | Active comparator | Patients receive information about the LINC group. Receives: Other: educational intervention; Other: questionnaire administration; Other: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in perceived self-efficacy pre-intervention and post-intervention.
Modify the Perceived Efficacy in Patient-Physician Interactions (PEPPI) to measure patient confidence in talking with their employer. The revised version will focus on patients' level of confidence in discussing employer accommodation and seeking support from their employer. The PEPPI is a brief ten-item measure that asks patients to rate on a Likert scale their confidence in communicating. It is a widely used measure with strong psychometric properties anchored at 5 - "very confident" and 1 - "not at all confident." Thus, the investigators plan to evaluate communication self-efficacy before and after patients in the experimental group view the DVD to explore changes in perceived self-efficacy as a result of communication training. The investigators will compare this change with changes in the control group patients' perceived self-efficacy by matching the timing of the pre-post administration of the measure in both groups.
Measured: Baseline to up to 52 weeks
Compare requested pre-intervention measures to received post-intervention measures.
During the baseline (pre-intervention) interview patients will answer these questions about specific workplace topics the patients is interested in discussing with their employer, such as available accommodations. During the interviews, each patient will complete a matched questionnaire asking about whether or not they discussed these topics. A score of "1" on the pre-intervention measure indicates patients wanted to discuss the item and the same score on the post-interventions measures indicates that this topic was discussed. A score of "0" in the post-intervention measure indicates that this expectation was not met.
Measured: Baseline to up to 52 weeks
Compare longitudinal changes in knowledge scale before and after combination information and communication skills training.
To aid knowledge acquisition, the investigators have linked didactic teaching with video recorded scenarios exemplifying use of knowledge and skills to achieve increased knowledge. The investigators have developed a knowledge measure and in collaboration with Dr. Dumenci will rigorously test the scale. The investigators will then use this scale to determine whether patients' knowledge improves as a result of the combination of information and communication skills training proposed in this intervention. Therefore, knowledge will be measured before the intervention and after the intervention. The investigators will then compare the experimental and control groups' longitudinal changes in knowledge.
Measured: Baseline to up to 52 weeks
Secondary outcomes (2)
Compare the amount of weekly hours worked between treatment and control arms.
Compare weekly hours of work between the treatment and control arms
Measured: Baseline to up to 52 weeks
Compare the amount of employed vs non-employed subjects between treatment and control arms.
Compare employment status (employed vs non-employed) between the treatment and control arms.
Measured: Baseline to up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionOct 2015
Why it stopped: Grant ended/funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard Brown, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895490
- Sponsor's protocol ID
- MCC-14021
- Other IDs
- NCI-2013-02478, HM14021, MCC-14021
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Communication Training to Promote Employment Retention Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT02895490
- Acronym / sponsor ID
- MCC-14021
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant ended/funding unavailable
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies communication training in promoting employment retention among cancer patients. Communication training may improve patient-employer communication and increase the likelihood that cancer patients will remain employed, reduce patients' time away from work, and increase workplace accommodations that enable patients to balance treatment and work.
Detailed description
PRIMARY OBJECTIVES:
- Demonstrate the efficacy of the DVD intervention to a) increase patients' knowledge of their legal rights in the workplace, b) improve patient perceptions of workplace communication about the impact of cancer treatment and ongoing surveillance, and c) increase the number of requested and received workplace accommodations.
II. Compare employment status (employed vs non-employed) between the treatment and control arms.
III. Compare weekly hours of work between the treatment and control arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients receive a DVD containing educational information about patients' legal rights in the workplace and communication skills demonstrated through four scenarios depicting a variety of employer-employee communication challenges for patients, provided by the Legal Information Network for Cancer (LINC) group.
Arm II: Patients receive information about the LINC group
After completion of study, patients are followed up at 4, 12, and 52 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (DVD) | Experimental | Other: educational intervention, Other: communication skills training, Other: questionnaire administration, Other: quality-of-life assessmentPatients receive a DVD containing educational information about patients' legal rights in the workplace and communication skills demonstrated through four scenarios depicting a variety of employer-employee communication challenges for patients, provided by LINC group. |
| Arm II (control) | Active comparator | Other: educational intervention, Other: questionnaire administration, Other: quality-of-life assessmentPatients receive information about the LINC group. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with a new, primary diagnosis of a solid tumor
- Employed full- or part-time at the time of enrollment
- English-speaking
- Able to participate in telephone interviews
- Able to view a 1-hour DVD
Key exclusion criteria (1 listed)
- Patients with prior cancer except non-melanoma skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational interventionAlso: intervention, educationalReceive a DVD containing educational information and communication skills | Other | Arm I (DVD) |
| communication skills trainingReceive a DVD containing educational information and communication skills | Other | Arm I (DVD) |
| educational interventionAlso: intervention, educationalReceive information about the LINC group | Other | Arm II (control) |
| questionnaire administrationAncillary studies | Other | Arm I (DVD), Arm II (control) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (DVD), Arm II (control) |
Primary outcome
Changes in perceived self-efficacy pre-intervention and post-intervention.
Time frame: Baseline to up to 52 weeks
Modify the Perceived Efficacy in Patient-Physician Interactions (PEPPI) to measure patient confidence in talking with their employer. The revised version will focus on patients' level of confidence in discussing employer accommodation and seeking support from their employer. The PEPPI is a brief ten-item measure that asks patients to rate on a Likert scale their confidence in communicating. It is a widely used measure with strong psychometric properties anchored at 5 - "very confident" and 1 - "not at all confident." Thus, the investigators plan to evaluate communication self-efficacy before and after patients in the experimental group view the DVD to explore changes in perceived self-efficacy as a result of communication training. The investigators will compare this change with changes in the control group patients' perceived self-efficacy by matching the timing of the pre-post administration of the measure in both groups.
Compare requested pre-intervention measures to received post-intervention measures.
Time frame: Baseline to up to 52 weeks
During the baseline (pre-intervention) interview patients will answer these questions about specific workplace topics the patients is interested in discussing with their employer, such as available accommodations. During the interviews, each patient will complete a matched questionnaire asking about whether or not they discussed these topics. A score of "1" on the pre-intervention measure indicates patients wanted to discuss the item and the same score on the post-interventions measures indicates that this topic was discussed. A score of "0" in the post-intervention measure indicates that this expectation was not met.
Compare longitudinal changes in knowledge scale before and after combination information and communication skills training.
Time frame: Baseline to up to 52 weeks
To aid knowledge acquisition, the investigators have linked didactic teaching with video recorded scenarios exemplifying use of knowledge and skills to achieve increased knowledge. The investigators have developed a knowledge measure and in collaboration with Dr. Dumenci will rigorously test the scale. The investigators will then use this scale to determine whether patients' knowledge improves as a result of the combination of information and communication skills training proposed in this intervention. Therefore, knowledge will be measured before the intervention and after the intervention. The investigators will then compare the experimental and control groups' longitudinal changes in knowledge.
2 secondary outcomes
Compare the amount of weekly hours worked between treatment and control arms.
Time frame: Baseline to up to 52 weeks
Compare the amount of employed vs non-employed subjects between treatment and control arms.
Time frame: Baseline to up to 52 weeks
Results and safety
The study was stopped early (reason given: Grant ended/funding unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brown principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, communication skills training and questionnaire administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Grant ended/funding unavailable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in perceived self-efficacy pre-intervention and post-intervention. (time frame: Baseline to up to 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.